Search Results

The Medtronic Sofamor Danek Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

The Medtronic Sofamor Danek Cement Restrictor is NOT intended for any spinal indications.

Not Found

I apologize, but the provided text from the FDA 510(k) letter for the "Cement Restrictor" device does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria.

This document is a letter from the FDA stating that the device is "substantially equivalent" to a legally marketed predicate device. It primarily focuses on:

• Confirming substantial equivalence.
• Specifying the "Indications For Use" (cement restrictor in orthopedic surgeries like hip stem and total knee replacement).
• Crucially, stating a warning about spinal indications: "WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED." This implies that no study was performed or proven for spinal use.
• Regulatory requirements and contacts.

As a result, I cannot provide the requested table or answer the specific questions about acceptance criteria and a detailed study because that information is not present in the provided text. The 510(k) process for substantial equivalence often relies on demonstrating similarity to an existing device rather than requiring extensive new clinical trials with detailed performance criteria like those you've asked about for novel devices.

Ask a specific question about this device